FDAnews Drug Daily Bulletin

FOCUS GROUPS WILL EXAMINE DTC ADVERTISING, PHYSICIAN LABELING

Dec. 7, 2005
A A

The Center for Drug Evaluation and Research (CDER) plans to conduct focus group studies on a number of topics in 2006, including direct-to-consumer (DTC) advertising and physician labeling.

The agency typically uses focus groups to help it develop policy initiatives, according to a Federal Register notice.

CDER didn't reveal the exact nature of the focus groups, but the FDA has been examining both issues in recent months. The agency acknowledged earlier this month that it is considering new rules for DTC advertising to ensure that promotions contain balanced messages. The FDA is also drafting a final physician labeling rule that would create a standardized labeling format and require risk information to be placed more prominently on drug labels.

Overall, CDER intends to conduct 20 focus group studies annually, with approximately 10 focus groups and 200 focus group sessions per study, the FDA said. Other planned topics for focus groups include medication guides, OTC drug labeling and risk communication.